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Study on the effect of Press needle on overactive bladder with anxiety symptoms based on the theory of ear vagus nerve stimulation

Study on the effect of Press needle on overactive bladder with anxiety symptoms based on the theory of ear vagus nerve stimulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001478
Enrollment
Unknown
Registered
2025-07-26
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder and anxiety

Interventions

Control group (behavioral therapy):Medication + behavioral therapy (pelvic floor muscle training lifestyle changes and urination training)
Experimental group (needle pressing group):On the basis of the control group+First 75% alcohol was used for routine disinfection. The lancet was buried in the ear and heart CO15 liver CO12 kidney CO10

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Outpatients or inpatients female patients aged 18–65 years with a disease duration of more than 2 months; Meeting the diagnostic criteria for overactive bladder (OAB) as defined in the Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases (2025 edition); Classified as the Kidney Deficiency with Damp-Heat syndrome according to traditional Chinese medicine (TCM) differentiation; Capable of using a voiding diary; OAB Symptom Score (OABSS) between 3 and 11 (inclusive); OABSS = 2 is considered asymptomatic thus only patients with mild to moderate OAB are included. Hamilton Anxiety Scale (HAMA) scores between 7 and 29 (inclusive) indicating mild to moderate anxiety symptoms; Providing informed consent voluntarily. The informed consent process must comply with Good Clinical Practice (GCP) guidelines.

Exclusion criteria

Exclusion criteria: 1) Patients with acute infections or urinary tract infections; 2) Patients with bladder pain syndrome interstitial cystitis; pregnant breastfeeding or planning to become pregnant; patients with severe hypertension or unstable blood pressure control; patients with severe heart brain liver kidney or blood diseases; 3) Patients with contraindications to acupuncture; those with a history of needle phobia and fear or resistance to acupuncture treatment; 4) Exclude patients with OABSS (Overactive Bladder Symptom Scale) =12 (severe OAB) or OABSS =2 (no OAB) or HAMA (Hospital Anxiety and Munchausen's Hypochondriac Checklist) =30 (severe anxiety) or HAMA =6 (no anxiety); 5) Patients with skin allergies or other skin conditions; 6) Patients diagnosed with anxiety disorder or depression.

Design outcomes

Primary

MeasureTime frame
Serotonin levels in the blood;Daytime frequency urgency frequency and nocturia frequency;Anxiety relief response rate;Overactive Bladder Symptom Score ;

Secondary

MeasureTime frame
Traditional Chinese Medicine symptom score and efficacy evaluation;Maximum urine flow rate and residual urine volume and maximum bladder capacity;Hamilton Depression Rating Scale and Pittsburgh Sleep Quality Index ;International Incontinence Consultation Questionnaire-Overactive Bladder Questionnaire ;Serum neutrophil-to-lymphocyte ratio (NLR);

Countries

China

Contacts

Public ContactZhou ping

Jiangsu Province Academy of Traditional Chinese Medicine

834511175@qq.com13776630616

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026